MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON T BR ANCHOR W/OC; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	210812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: the product has not returned to j&j medtech orthopaedics, however a photo was provided for evaluation.¿ visual inspection of the returned photo found the anchor still attached to the inserter and broken at the distal end, the anchor had foreign matter at the distal end.No other anomalies could be observed.The overall complaint was confirmed as the observed condition of the gryphon t br anchor w/oc would have contributed to the complained device issue.Device history review: a review of the device history record was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.¿ based on the investigation findings, the potential cause for the reported condition is traced to the procedural variables, such handling of the device or product interaction during procedure.The possible root cause can be associated with off axis insertion and levering during insertion.As per the instructions for use, axial misalignment or levering with the anchor upon insertion, may result in anchor or inserter fracture.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported that during a ankle joint ligament repair surgery, the gryphon t br anchor w/oc was broken off.It was reported that all broken parts were removed.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H.11.Additional narrative: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection found that the device had the anchor still attached to the shaft and broken at the distal end.Not all the broken fragments were returned for evaluation.One suture was detached from the inserter and had a fragment of the anchor attached to it.The device had foreign matter, presumably biological matter.No other anomalies were noted.The overall complaint was confirmed as the observed condition of gryphon t br anchor w/oc would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure.The possible root cause can be associated with off axis insertion and levering during insertion and sub-consequently led the anchor to break/damage.As per the instructions for use, 1) axial misalignment or levering with the anchor upon insertion, may result in anchor or inserter fracture.2) apply tension (normal force) on suture lengths, as excessive force may overload the anchor or suture.Properly handling and attention to the approved use of the device diminishes the risk of failure.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: a review of the device history record was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: d4.Expiration date; d4.Primary udi number; h4.Device manufacture date: updated accordingly.

• Brand Name: GRYPHON T BR ANCHOR W/OC
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SÃ RL; chemin blanc 38; le locle CH-02 400; SZ CH-02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 23066825
• Report Number: 1221934-2025-03547
• Device Sequence Number: 9681049
• Product Code: MAI
• UDI-Device Identifier: 10886705001262
• UDI-Public: (01)10886705001262(10)220L349(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 210812
• Device Lot Number: 220L349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 09/23/2025; 10/28/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/01/2025; 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown